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Trial record 1 of 1 for:    NCT01886235
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Intravital Microscopy for Identifying Tumor Vessels in Patients With Stage IA-IV Melanoma That is Being Removed by Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01886235
First Posted: June 25, 2013
Last Update Posted: July 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute
Results First Submitted: March 30, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions: Recurrent Melanoma
Stage IA Skin Melanoma
Stage IB Skin Melanoma
Stage IIA Skin Melanoma
Stage IIB Skin Melanoma
Stage IIC Skin Melanoma
Stage IIIA Skin Melanoma
Stage IIIB Skin Melanoma
Stage IIIC Skin Melanoma
Stage IV Skin Melanoma
Interventions: Procedure: Diagnostic Microscopy
Drug: Fluorescein Sodium Injection
Other: Laboratory Biomarker Analysis
Procedure: Therapeutic Conventional Surgery

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Diagnosis (Intravital Microscopy)

Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.

Diagnostic Microscopy: Undergo intravital microscopy

Fluorescein Sodium Injection: Given IV

Laboratory Biomarker Analysis: Correlative studies

Therapeutic Conventional Surgery: Undergo surgery


Participant Flow:   Overall Study
    Diagnosis (Intravital Microscopy)
STARTED   10 
COMPLETED   10 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All treated and eligible patients

Reporting Groups
  Description
Diagnosis (Intravital Microscopy)

Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.

Diagnostic Microscopy: Undergo intravital microscopy

Fluorescein Sodium Injection: Given IV

Laboratory Biomarker Analysis: Correlative studies

Therapeutic Conventional Surgery: Undergo surgery


Baseline Measures
   Diagnosis (Intravital Microscopy) 
Overall Participants Analyzed 
[Units: Participants]
 10 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      8  80.0% 
>=65 years      2  20.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.5  (10.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      5  50.0% 
Male      5  50.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      10 100.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Successful Intravital Microscopy on Accessible Human Melanoma Tumors During Standard Local Excision   [ Time Frame: Up to 2 months ]

2.  Secondary:   "Percentage of Participants With Any Adverse Event   [ Time Frame: Up to 5 years ]

3.  Secondary:   Blood Flow Rates   [ Time Frame: Up to 2 months ]

4.  Secondary:   Complication Rate   [ Time Frame: Up to 5 years ]

5.  Secondary:   Median Overall Survival   [ Time Frame: Up to 5 years ]

6.  Secondary:   Median Progression Free Survival   [ Time Frame: Up to 5 years ]

7.  Secondary:   Percentage of Participants With Treatment Response   [ Time Frame: Up to 5 years ]

8.  Secondary:   Tumor Vasculature   [ Time Frame: Up to 2 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Senior Administrator, Compliance - Clinical Research Services
Organization: Roswell Park Cancer Institute
phone: 716-845-2300



Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01886235     History of Changes
Other Study ID Numbers: I 231512
NCI-2013-01052 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
I 231512 ( Other Identifier: Roswell Park Cancer Institute )
P30CA016056 ( U.S. NIH Grant/Contract )
First Submitted: May 30, 2013
First Posted: June 25, 2013
Results First Submitted: March 30, 2017
Results First Posted: June 6, 2017
Last Update Posted: July 2, 2017